Friday, April 12, 2024 1:12:53 PM
Yes, that little piece of information is key to understanding that the “fitting out” of at least one operational clean room is likely being described. This model then can be replicated site wide and “franchise” wide based on an approved model. Since at least one clean room likely is or will be being fitted out with GMP grade units and the “site” has already been GMP certified, any final inspection, barring any unforeseen additions or subtractions, will likely be able to pass all GMP commercial scale final inspections. Within this scenario is the outside chance that multiple clean rooms are being approved at the same time as a site buildout.
I have long expected that at least one clean room would be Flaskworks fitted out to compare against artisan during the approval process and that still may be in play. If anyone has any question at all about why this has taken SO long since last patient enrollment, one word… manufacturing, manufacturing, manufacturing. Your mention of price concerns, which point to NICE input, have also certainly been part of the equation in subterfuge. Patient demand being matched with product availability is indeed cost related as most patients simply will not have the funds needed to pay for treatment themselves but the funds must come from a pool. Endless funding is not available except at the FED and IMF and even they are controlled by the puppeteers. Best wishes.
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